TOXICOLOGICAL EVALUATION OF MIGRATORY FOOD ADDITIVES*
John P. Frawley
Hercules Incorporated, Wilmington, Delaware

This month we observe the eighth anniversary of the enactment of the
Food Additives Amendment.

Many of you will remember the Congressional hearings

prior to the enactment, the pleas of many that packaging materials should be
covered by a separate law specifically drafted for indirect additives, the
last minute debate on the Delaney Clause and some of the predictions of the
effect of the law on industry and new product development.
Perhaps everyone was right, to a degree.

The law was enacted> with a

modified Delaney Clause, industry spent more time and money than anyone predicted,
new product development and improvement have been delayed, and above all—food
packaging should have been,covered by a separate law specifically conceived and
drafted for this complex group of materials.
However, eight years ago, we all accepted the fact that it was now
the law of the land and that "any substance the intended use of which---------- may
reasonably be expected to result, directly or indirectly, in its becoming a
component-------of any food" was a food additive and required approval of the Food
and Drug Administration before use.

Little did we realize what was in store

for us, but we all put our best foot forward in an attempt to make the law work.
I will not criticize anyone—except perhaps myself—because the motivation of
everyone certainly was sincere.

However, in our haste to comply, we proceeded

without proper insight and knowledge of food packaging problems and are guilty
of creating an unnecessarily complex maze of regulatory procedures.
Anyone who has the misfortune of trying to keep abreast of food packaging
regulations realizes the complexity of our evolved system.

The Lord's Prayer

■^Manuscript presented at the American Chemical Society Symposium on Safety
Evaluation of Coatings and Plastics for Food Packaging, September lk, 1966,
New York City.

00001474

- 2 contains

56 words, the Ten Commandments 300 words, the Declaration of Independence

3,000 words.

So-far, our food packaging regulations contain over 43,000 words,

about 10,000 words more than the regulations on all intentional food additives-for which the law was principally drafted.
Even a superficial examination of these regulations reveals that the
vast majority of these words are devoted to the enumeration of thousands of
chemicals for one or more specific uses under which most cannot migrate to food
at an unsafe level regardless of their degree of toxicity.

The one unanticipated

result of this extensive cataloging of every chemical which remotely may come
in contact with food, has been a growing apathy toward correct interpretation
of the.regulations.

Unless you work with these regulations daily, are familiar,

with the multiple cross-references, and have sufficient technical training to
understand what chemicals are covered by some of the vague generic terms, it ‘is
almost impossible to determine the approved uses of a given chemical.

It is

easy to understand why two manufacturers almost invariably will give conflicting
statements about the food packaging status of the same product.
Above and beyond the problem of our inability to determine with certainty
the status of a given chemical under the regulations, I am more concerned about
the waste of our resources on matters which can be of no public health significance.
Those of us in industry, government, or universities who apply our professional
knowledge and judgment to problems in the field of environmental health have the
moral responsibility to invest our limited resources in a manner which will give
us the greatest return in terms of health protection.

To silently and passively

allow our energies to be diverted into predictably unprofitable research is
beyond the dignity of any professional individual.

Nevertheless, with each

passing year there is more evidence of this type of research being conducted
I
by myself and others. It would be tragic if history reports that our generation
squandered its time and money on trivialities.

Indeed, many of our investigations

in the field of food packaging have fallen into this category.
ASI 00001475

- 3 Industry and government Jointly are responsible for the current state
of regulation of food packaging materials.

In defense of us all, I must restate

the fact that we had very few guidelines to serve as a basis for a more
intelligent approach.

However, in the eight years which have intervened* we have

learned much and many of our previous assumptions are no longer valid or
necessary.

It is this experience which I wish to review today and to offer a

modest start toward a major change in the scientific and regulatory approach to
food packaging materials.
The basic procedure for the evaluation of safety of any food packaging
material is very clearly and succinctly stated in the Pood Additives Amendment
09(c)(5)7", "the Secretary shall consider among other relevant factors:
(a) the probable consumption of the additive-------------- ---(B) the cumulative effect of such additive in the diet of manor animals--—- —
(C) safety factors which in the opinion of experts-—are generally
recognized as appropriate for the use of animal experimentation
data•"
In actual practice, this means that it is necessary to know the probable
consumption by man, the "no effect" level in experimental animals as determined
by a two-year chronic toxicity study, and that a 100-fold margin of safety
exists between these two.
The concept of the 100-fold margin of safety is generally recognized
as a conservative approach to safety evaluation of food additives, and has
been almost universally adopted in all developed countries.

It is predicated

on an assumption that the average human might be 10 times more susceptible to
a given chemical agent than the most sensitive animal, and that some humans
might be 10 times more susceptible than the average human, due to differences
in body weight, food intake and habits, state of health, rate of metabolism, etc.

ASI 00001476

The 100-fold, margin of safety frequently has been criticized as unduly
coriservative, but in the absence of direct human experimentation, it has served
the profession veil.
The first slide shows this relationship in its simplest form.

If

the probable consumption by man will be 0.01 ppm in the total diet, the minimum
"no effect" level in experimental animals must be at least 1 ppm.

Likewise, a

consumption level of 0.1 ppm must be accompanied by a "no effect" level of
10 ppm, and so on.
Let me state the proposition a little differently.

For a compound

which becomes a component of man’s diet at a level of 0.1 ppm, to be considered
unsafe for this use, it would have to exert a toxic effect in experimental
animals at a level of 10 ppm.
As I stated earlier, environmental health specialists have a professional
responsibility to invest our resources in a manner which is most likely to
protect or improve the health of the community.

Therefore, I have attempted

an analysis of the probability of detecting a potential health hazard from the
use of a chemical of unknown toxicity which might be present in man's diet at
any given concentration.
After considering several possible approaches to this analysis, I
decided the most logical basis was to review as many of the two-year chronic
toxicity studies as I could find and to tabulate the "no effect" level confirmed
for each.

I can make no claim that I have found every two-year chronic toxicity

study which has been conducted.

I can only claim that I have tabulated the

"no effect" levels from every chronic study which I could find, without any
selection or rejection.

In total, I was able to locate two-year chronic

toxicity studies on lk3 different substances, and although this may seem like a
modest number, it represents between 7 and 10 million dollars in toxicologic
i

research.

Undoubtedly, these 1^3 represent a large percentage of all such

ASI 00001477

- 5 studies which have been conducted and, I believe, constitute a representative
cross-section.
Slide 2 provides a tabulation of the "no effect" levels for all of
these 143 compounds.

It is apparent from this tabulation that a small percentage

of compounds will be extremely toxic-----having a "no effect" level in experimental
animals below 1 ppm, but that the majority will exhibit no toxic effect even
at 100 ppm.

Only 11 out of the 1^3 compounds demonstrated any toxic effect

below 10 ppm.

We might conclude that the odds of detecting a toxic effect

at 10 ppm from an "unknown" compound are approximately 1 in 10.
Let us now look at this tabulation a little more closely and examine
the nature of these 11 compounds which are toxic at 10 ppm or less.

The next

slide (3) shows the same information as the previous slide, except two additional
columns have been added which subdivide these 1^3 compounds into two categories:
1) a heavy metals and pesticide category and 2) an all other category.
this breakdown is worthy of careful examination.

I believe

The most apparent conclusion

is that all 11 of the compounds, which were toxic below 10 ppm, were pesticides
and heavy metals.

I suspect every toxicologist could name these compounds with

only a little reflection.

Equally significant is the fact that 23 of the 24

compounds which were toxic below 100 ppm in experimental animals, were also
pesticides or heavy metals.

The only compound in the "other" category which was

toxic below 100 ppm was acrylamide.
It is obvious that the degree of toxicity of pesticides and heavy
metals (which were used as pesticides at one time) is quite different from
that of other commercial chemicals.

This should represent no surprise because

pesticides are synthesized, screened and selected for their toxicity to one
or more forms of life before becoming commercial products.
Therefore, if we1exclude heavy metals and pesticides from our
consideration, experience has indicated that only a very occasional

ASI 00001478

- 6 (approximately 1 out of 100) commercial compound will have a "no effect" level
below 100 ppm and that an infinitely small number will exhibit any toxicity
at 10 ppm or less.
Let us pause for a moment to consider whether this distribution of
"no effect" levels is representative of commercial chemicals which might reach
the consumer.

Although 106 compounds may represent a large fraction of all

the chronic oral toxicity studies ever conducted, they represent a very small
fraction of all chemical compounds.

It can be argued that those compounds

which are selected for chronic toxicity studies may be Hess toxic than a completely
random selection of chemicals from a handbook.

Indeed, other highly toxic

chemicals, besides pesticides and heavy metals, have been identified by the
profession in acute and subacute inhalation and dermal studies in an attempt
to establish safe levels of these materials in the work environment.

However,

,

these compounds are invariably highly reactive compounds which are used to
synthesize other, more stable chemicals which become commercial products.
Because of their reactivity, they could not be a component of a finished
cofflmerieal product.

This is especially true for food containers which by

their very nature must be highly inert products and in their finished form
must contain only components which are resistant to chemical change.
Consequently, within the self-limiting features of a component of
food packaging, I believe the sampling is representative and justifies the
following conclusion:

Toxicological experience has indicated that, except for

pesticides and heavy metals, any compound which might be used as a component
of a finished food package or container, will be nontoxic to experimental
animals at a dietary level of 10 ppm.
To express this conclusion slightly differently, I would like to
show slide 4.

This slide dihows the probability of detecting an unsafe

ingredient when expressed in terms of the probable consumption by man.

In

this slide the 100-fold margin of safety has been applied to the animal data

ASI 00001479

-

7

-

to express the corresponding safe level for man.

It can he seen that at a con­

sumption level of 0.1 ppm (corresponding to the 10 ppm level in the experimental
diet) the probability of proving a compound to be unsafe approaches zero.
Therefore, any component of a food package which contributes no more than 0.1 ppm
to the human diet is generally recognized as safe, provided it is not a pesticide
or heavy metal.
I invite your serious reflection on this conclusion.

I have given it

much thought and I sincerely believe it provides greater consumer protection
than many of our widely accepted precepts.
Now let us for a few minutes consider the other aspect of the procedure
for evaluating the safety of food packaging materials--the determination of the
"probable consumption" by man.

If we are to make any progress in our goal of

investing our time and talent in projects which are most likely to give some

*

return on the investment in terms of health protection, we desperately need some
guidelines

for calculating the consumption by man.
There is no doubt in my mind that Congress did not intend that every­

thing which remotely may come in contact with food should be considered a component
of food.

Yet, this is precisely what we have done, and I place as much blame on

industry for this situation, a3 on government.

Most of this problem has been

the direct result of our advances in analytical chemistry.

Our extremely sensitive

analytical methods have made it impossible to prove the lack of migration of
almost any compound.

Consequently,

in the administration of our food laws, we

have denied the existence of zero, because we can't prove it.

To me this is

analogous to denying the existence of night because we can't prove the absence
of light.

Obviously, we have not reached the degree of sophistication necessary

to categorically say, "something is nothing 1" and then forget about it.
Realistically, at least for the time being, we must accept the concept that any
compound which is used in a food container, or used in the manufacture of a food

ASI 00001480

- 8 container, may reasonably be expected to become a component of food even if
only at a molecular concentration.

This concept does not mean, however, that

all of these uses involve any conceivable hazard to health, or that they require
regulation under the law to assure their safe use.

The question we continually

ask ourselves is: "Which do not?"
Let us consider our concept that a food packaging component which
contributes less than 0.1 ppm to the human diet is generally recognized as safe
and evaluate our experiences on migration studies in an effort to determine
which uses of packaging components will not exceed that level.
First of all, it is obvious to everyone, that any major component of
a food container must be assumed to possess the capability of migrating to food
at a biologically significant level, unless proven otherwise.

It is to protect

against this possibility that food packaging materials were included in the laV.
However, it is equally obvious to everyone, that at some level of addition, minor
components cannot become a component of the diet at a level in excess of a
generally recognized as safe concentration—0.1 ppm.

Is that level 0.01$, 0.1$,

or 1.0$?
I would like to assure you that this has not been an easy question to
answer.

I spent many a sleepless night trying to come to grips with the problem

until I realized that I was still applying many of the uninformed assumptions
which we made shortly after the Food Additives Amendment was passed.
At that time we were faced with compliance without any guidelines
on industry practice.

Toxicologists, like myself, who knew little about food

packaging industry were given the assignment of investigating the safety of
current industry practices.

Guidance was essentially nonexistent because the

food packaging industry is not a single entity, but a heterogeneous mixture of
'manufacturers, plastic and paper converters, can manufacturers, and

ASI 00001481

- 9 chemical suppliers, just to name a few.

Bach segment of the industry offered

different advice on how to proceed, varying from petitioning for everything
used by the industry to assuming everything was exempt.

In order to start the programs in the evaluation of safety of these
materials it was necessary to make certain assumptions about industry practices
and degree of migration.

Because there were essentially no facts to serve as

guidelines, the assumptions which were made were ultra-conservative.
In the beginning, in. order to estimate the maximum possible contribution
to the diet of man, we generally proceeded as follows:

determine the maximum

concentration at which an additive might be present in the container (which in
the case of processing adjuvants was based on an assumption of 100$ retention),
assume that the entire diet of man would be in contact with that container,
assume that this diet would be packaged in the smallest container giving the
greatest "surface to food" ratio and finally assume 100$ migration of the
additive to the food.

A few calculations by this method soon revealed that

everything could be a significant migrant to food—evai a compound which might
be present in the container at 1 ppm.
The next step which many investigators followed was to determine the
degree of migration.

For the vast majority of packaging chemicals, specific

and sensitive analytical methods were not available for detection in food, and,
as an analytical expediency, simulated solvents were used--water, dilute acid
and alkali, hexane, etc.

The saving in analytical costs was^significant, but

such studies have given us very little useful information on the amount of an
additive contributed to the diet of man.

I even question whether the savings

in analytical costs have not been offset by unnecessary toxicological and
administrative expenses.

As a net result of these studies we were able to

I
prove that everything could be a migrant at significant levels.

ASI 00001482

-

10

As far as the other assumptions are concerned, we still are without
reasonable guidelines which will permit us to calculate the "probable consumption
of the additive".

I would like to direct attention to this phrase "probable

consumption of the additive", because this is a quote from the Pood Additives
Amendment, and this is the level which we and the Secretary of HEW are
directed to consider--not the maximum possible consumption.

And to determine

this number, we still need many guidelines which are not available.

Who can

tell us what percent of the diet is exposed to uncoated paper or to plastic
film?

What fraction is dry, aqueous and fatty food?

storage temperature and time?

What is the average

The average "surface-to-food ratio"?

The same

questions can be asked of each segment of the industry, adhesive, rubber,
can manufacturers, and in each case quite different answers will be received.
In the absence of such fundamental yardsticks we are, still assuming

'

that every chemical which even fleetingly comes in contact with food is a food
additive requiring proof of safety and regulation under the law.
As I mentioned a few moments ago, I have wrestled with this problem
of trying to assign reasonable values to these various parameters.

After many

unsuccessful attempts, I decided to abandon this conventional approach which
we developed for want of facts, and to look at the data which has been developed
in recent years on "true" migration to food.
By "true" migration, I refer to a study, in which the packaging
component is incorporated into the substrate at its maximum functional level,
and exposed to food under ordinary or slightly exaggerated storage conditions,
followed by analysis of the food to determine the level of migration of the
component.

This type of study is the only type which can give any reasonable

information on the "probable consumption" by man.
I
In Hercules, we have synthesized several radioactive packaging components —
starting with polypropylene and polyethylene, alkylketene dimer, polyamide

i1
ASI 00001483

-

11

epichlorohydrin resin, several rosin esters and rosin size for the purpose of
conducting migration studies.

However, in order to find some basis for resolving

the question, "what level of a packaging component would give less than 0.1 ppm
to the diet of man?" I have selected the product which is most readily extracted
from its substrate--rosin size.

This material is an apt choice because it is

not only readily soluble in fats and oils, but also possesses appreciable
water solubility.

I believe that rosin 3ize is representative of the most readily

migratable food packaging material.

Moreover, paper, the substrate for rosin

size, is well known to be the "least resistant to penetration and extraction of
all the packaging media.

All of the technical facts argue that data from a

study on the migration of rosin size from paper should represent a maximum for
a component of any packaging media.

Indeed, such data would be excessive for

most uses of packaging components.
Let us now review the data on rosin size.

All of these data have been

published*, the details of which you can check at your leisure.

As our first

attempt at evaluating the level contributed to the diet, we used the typical
simulated solvents.

This was wasted effort, because in water and oil, the

extraction was a direct function of time and temperature, and did not plateau
until essentially 100$ of the rosin size was extracted or the integrity of the
paper sheet was destroyed.

The impractical!ty of this approach was obvious.

First of all, liquids are not packaged in uncoated paper and years of commercial
experience with rosin sized paper had demonstrated it to be a suitable packaging
material, with adequate shelf life.

These extraction tests did confirm, for

our purposes today, that rosin size on paper is an apt example of the extreme
in tendency to migrate.
As a consequence of the failure of the simulated solvent test to help
define the level of consumption, we prepared samples of radioactive rosin size,
I
incorporated them into typical commercial paper and paperboard at known levels,
*R.W.Davison, L.R. Kangas, R.M. Miller and S.H. Watkins, "Migration of Rosin
Components from Sized Paper to Exposed Foods", TAPPI Vol. U8, No. 8, August 19&5•

ASI 00001484

-

12

packaged a wide variety of food in contact with these paper samples at
typical package ratios, stored them at typical storage temperatures for typical
storage times and determined the rosin size content of each food by counting the
radioactivity.
The study was far more extensive than I will touch on today, because
we used several types of paper (greaseproof, waxed, unwaxed, etc.), containing
three different levels of rosin size, 2k different types of food (water, ice
cream, oysters, apricots, green beans, wheaties, sugar, doughnuts, hamburger,
butter, bacon, sausage, to name just a few) and analyzed each sample at several
different storage intervals and temperatures.

For our purposes today, 1 have

selected only the uncoated and unwaxed paper and only the maximum migjWitive
levels obtained for the 18 commodities packaged in these uncoated papers under
typical commercial storage conditions.

Admittedly this gives unrealistic

values for rosin size which are not typical of industry practice, but for our
present purposes, the worst case must be presented.
Slides 5, 6, and 7 show the maximum migration value for 18 food
commodities at various typical storage times and temperatures when exposed to
paper containing an average of 4$ rosin size.

It is obvious from some of these

values that high levels of migration can occur with some foods, whereas other
foods contain much less rosin size.

I am showing you these slides quickly

since the individual values are of no great significance, but the composite of
these values can be helpful.

The next slide (8) shows the average consumption

of these various commodity groups in the U.S.*, the average migration to that
commodity group and a calculation of the probable level of rosin size in the
total diet, if 100$ of the diet were packaged in uncoated paper containing 4$
rosin size.
I
* U.S. Department of Agriculture Dietary Evaluation of Pood Used in Households
in U.S. 1961

ASI 00001485

- 13 As I mentioned previously, three different sizing levels were used
in these studies.

The next slide (9) shows the final dietary calculations

for the same foods, under the same conditions for paper containing 2$ and 1$
rosin size.

The extrapolation is remarkably good.

The last column shows

the migration in ppm's expressed on the basis of a unit of 1$ rosin size in the
paper or container.

For each percent addition to the container, if the entire

diet of man was in contact with that container, his diet would contain 2 ppm of
the additive.
Now I wish to carry this one step further to arrive at a realistic
determination of the "probable consumption by man".

Obviously, 100$ of man's

diet is not in contact with paper, or any other single type of food container.
There are 5 major types of food container substrates, glass, metal, paper,
plastic, and cellophane.

It is impossible to get reliable figures revealing

the percent of the food packaging market shared by each.

However, it is

conservative to assume that no more than 25$ of man’s diet is in contact with
any given type of food package or packaging additive.
The next slide (10) shows a final calculation of the probable
consumption by man which would result from the use of a component at a level
of 1$ in the container (as directly measured from the rosin size experiments)
and the probable consumption from a level in the container of 0.2$.

Undoubtedly,

this calculation is an exaggeration for most uses of packaging components which
possess greater insolubility or which are used in substrates more resistant to
penetration than paper.

Nevertheless, it permits the conservative conclusion

shown on the next slide (ll): "any component of an article contacting food which
is present in the article or its coating at a level not exceeding 0.2$ by weight
is generally recognized as safe, provided it is not a heavy metal or pesticide".
I respectfully submit this conclusion to you.

I do not contend that

the wording is ideal from the legal or administrative point of view.

However, I

ASI 00001486

- 14 believe it is scientifically sound and can be used as a basis for deleting
the majority of the trivial citations in Gubpart F of the regulations, and for
eliminating much of the waste of time and effort being devoted to problems
which can be of no possible public health significance.
To summarize these thoughts: toxicological experience has
demonstrated that the vast majority of chemicals are nontoxic to experimental
animals at 100 ppm in the total diet or higher.

Except for pesticides and heavy

metals, no compounds have been found to be toxic at less than 10 ppm.
Applying the conventional 100-fold margin of safety, it is safe to assume that
0.1 ppm in the human diet would be safe for any chemical which would be a
technically suitable component of a food container.

Experience from migration

studies have shown that a level of 0,2$ by weight of a component of a food
container will give less than 0.1 ppm to the human diet.

Any component, of an ,

article contacting food which is present in the article or its coating at a
level not exceeding 0.2$ by weight provided it is not a heavy metal or pesticide,
is unworthy of any scientific or administrative attention and is generally
recognized as safe.

ASI 00001487

SLIDE 1

obhxbal basis or iyaloatiom
of sawtx or food atditiybs

probable Consumption
by Man
O.OI ppm
O.I ppm
X.O Plan
10.0

ppn

Minimum "Wo Effect”
Level la Animals*
1 ppm

10 ppm
100 ppm
1000 ppm

* based on 2-year chronic experiment*

ASI 00001488

SLIDE 2

DISTRIBUTION OF "NO EFFECT"
LEVELS IN CHRONIC STUDIES
"No Effect"
Levels, ppm

All Cpds.
J3ST

< 1
*10
<100
<1,000
<10,000

3
11
24
59
108

ftSI 00001489

SLIDE 3
DISTRIBUTION OF "NO EFFECT" LEVELS IN CHRONIC STUDIES
'No Effect"
Levels
(ppm)
*1
■<10
<100
<1,000
<10,000

Others

11*2

Hvy. Metals
& Pesticides
07): _

HM

3
11
‘24
59
108

3
11
23
32
37

0
0
1
27
71

All Cpds.

ASI 00001490

SLIDE 4
PROBA^TT.TTY of detecting health hazards

IN PACKAGING APPLICATIONS
Probable Consumption
by Man
0.01 ppm
0.1 ppm
1.0 ppm
10.0 ppm

Probability of
Proving Unsafe
—> 0
—> 0
l/lOO
30/100

ASI 00001491

SLIDE.$
MAXIMUM MIGRATION OF ROSIN §3SE FROM UHCOATED PAPER
msrrora TYPICAL STORAGE CONDITIONS
fW ROSIN SIZE DT PAPER)
Time
tPaysl

Migration
tel~

34°
10°

14

5-9
0.3

34°
72°
34°
72°

T
14
7

Food

MilK Prod.
tatar
lea cream

28

Vemt table
beans

gi be&hs
ItitueA
pdtdtbei

28

1.3
4.1
2.4
0.2

fcSl

00001492

SLIDE 6

MAXIMUM MIGRATION OF ROSIN SIZE - CQN'T

2

Food

Temp.

Time

Migration
(ppm)

grd. beef
chicken
beefsteak
sausage

3k°
3k*
3k°
3k°

5
3
7
5

8.7
7.2
k.9
12k.0

72°
72*

28
28

0.1
1.2

Meats

Fruitb
apricots
apples

ASI 00001493

SLIDE 7
MAXIMUM MIGRATION OF ROSIN SIZE - CON'T
Food

3

Temp.

Time

Migration
iEESl

72“
34°
72°
72“

14
28
28
3

5-8
7.0
0.2
0.9

72“
34“

28
14

0.2
32.8

Grain Prod.
Puffed Rice
Wheaties
Flour
Doughnuts
Others
Sugar
Butter

ASI 00001494

SLIDE 8
galcuiajion of maximum migration

OF ROSIN SIZE TO TOTAL DIET
(1# ROSIN SIZE IN PAPERT
Commodity
Group

# of
Diet

Milk Prod.
31
20
Veget.
18
Meat
Fruits
13
Grain Prod. 10
Sugar
5
Butter, oils 3

Av. Migration
(ppm)
3.1
2.0
38.2
0.5
3-5
0.2
32.8

Contrib. to Total
Diet CPPmL
1.0
0.4
6.9
0.1
0.4
0.0

■

9.7 PI«n

ASI 00001495

SLIDE 9
MAXIMUM MIGRATION OF ROSIN SIZE TO DIET

Level of Size
in Paper,

PPM

PPM/*

9-7

2.4
2.2

1*

1-9

1.9

I

ASI 00001496

SLIDE 10
CALCULATION OF PROBABLE CONSUMPTION BY MAN

Max. Diet in contact
Max. Total Diet Migration

25$
2 ppm/ea. $

Cone, in Package

Probable Consumption

1.0$

0.5 ppm

0.2$

0.1 ppm

00001497

i

SLIDE 11

GRAS
ANY COMPONENT OP AN ARTICLE CONTACTING FOOD
WHICH IS PRESENT IN THE ARTICLE 0R ITS
COATING AT A LEVEL NOT EXCEEDING 0.2# BY
WEIGHT IS GENERALLY RECOGNIZED AS SAFE,
PROVIDED IT IS NOT A HEAVY METAL OR PESTICIDE.

a

T nfi00l498